BIONCaRT GmbH has received approval from the responsible federal authority, the Paul Ehrlich Institute, to conduct a Phase I/IIa clinical trial. The aim of the study is to investigate the safety and initial evidence of efficacy of umbilical cord tissue-derived mesenchymal stromal cells for the treatment of cartilage damage in the knee joint.
The clinical trial according to the German Medicines Act is entitled: “Phase I/IIa study to evaluate the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint”.
In close collaboration with eight renowned clinical trial centers, as well as partner institutions such as the Fraunhofer Institute for Cell Therapy and Immunology (IZI), which is responsible for manufacturing the clinical trial samples under GMP, the Polski Bank Komórek Macierzystych (PBKM), and the Coordination Center for Clinical Studies (KKS) Dresden at the TU Dresden, BIONCaRT will conduct the study over the coming months. The study will be led by Prof. Dr. Jörg Lützner, University Center for Orthopedics, Trauma & Plastic Surgery, Carl Gustav Carus University Hospital, TU Dresden.
“The approval of this study is a significant milestone for BIONCaRT and our partners. It brings us closer to our goal of providing access to cell-based regenerative therapies for all patients of all ages,” says Dr. André Gerth, Managing Director of BIONCaRT. “We thank the regulatory authority for their trust and our partners for their dedicated and competent cooperation.”
This study represents another important step for BIONCaRT on the path to clinical translation of innovative cell-based therapies. The results of the Phase I/IIa study will be crucial for the further development program and the approval process. “As local venture capitalists, we are delighted to be supporting BIONCaRT, a Central German life science company, on its path to clinical translation. The study that has now begun is an important step for the development of novel, cell-based therapies and simultaneously strengthens Saxony and Thuringia as biotechnology centers.” – Katja Butzmann, Managing Director, bm|t Beteiligungsmanagement Thüringen GmbH & Oliver Latz, Senior Investment Manager, TGFS Technologiegründerfonds Sachsen
Press Contact:
Dr. Heike Opitz
Managerin Business Development
BIONCaRT GmbH
+49 (0) 176 725 152 24
heike.opitz@bioncart.com
